FDA 510(k) Application Details - K080688

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K080688
Device Name	Mesh, Surgical, Polymeric
Applicant	ATRIUM MEDICAL CORP. 5 WENTWORTH DR. HUDSON, NH 03051 US Other 510(k) Applications for this Company
Contact	JOSEPH P DE PAOLO Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2008
Decision Date	04/16/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review